FDA Inspection 1031540 — Cerno Pharmaceutical
The FDA completed an inspection of Cerno Pharmaceutical on November 17, 2017 in Miami, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 17, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3578 | 21 CFR 211.101(c)(1) | Q.C. release check by second individual |